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An exploratory trial of the efficacy and safety of collagen corneal repair grafts (non-acellular corneal stroma) for corneal lamellar transplantation

An exploratory trial of the efficacy and safety of collagen corneal repair grafts (non-acellular corneal stroma) for corneal lamellar transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099180
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal disease

Interventions

Experimental group:The investigator performs lamellar corneal transplantation according to the specific condition of the subject, and the depth

Sponsors

Henan Provincial Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age of 18 to 80 years old, regardless of gender; (2) Patients with corneal disease without descemet's membrane and endothelial layer, who are scheduled for lamellar keratoplasty; (3) The subjects and/or their guardians could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) The affected eye is complicated by a disease that severely affects the ocular surface (such as severe dry eye, Sjogren's syndrome, cicatricial peebooid). sores, etc.); (2) The affected eye is combined with other ocular lesions (such as glaucoma, active uveitis, scleral staphyloma, infectious eye Internal inflammation, retinal detachment, eyelid insufficiency, ocular hypertension, etc.); (3) Patients with severe corneal vascularization; (4) Concomitant with major organ failure or other serious diseases that cannot tolerate surgery, including unintervened and severe of coronary or cardiovascular disease, or history of myocardial infarction within 12 months prior to enrollment; (5) Patients with psychiatric diseases, severe systemic diseases (such as severe diabetes mellitus (after taking glycemic control measures, Fasting blood glucose is still >= 8 mmol/L), uncontrolled hypertension above stage II (blood pressure is higher than after drug control 160~179/100~109 mmHg), rosacea); (6) History of allergy to commonly used ophthalmic drugs (tobramycin, dexamethasone, tacrolimus, etc.); (7) History of cornea or ocular surgery in the affected eye; (8) Those with severe allergies and/or allergies to the test materials; (9) Pregnant or lactating females; (10) Participation in other interventional drug clinical trials or medical device clinical trials within 3 months prior to enrollment; (11) Other situations in which the investigator believes that the investigator should not participate in this clinical trial for the benefit of the subject; (12) Corneal trauma such as severe burns or chemical injuries

Design outcomes

Primary

MeasureTime frame
Degree of corneal epithelial healing;Corneal thickness;Corneal transparency;

Secondary

MeasureTime frame
Corneal curvature;Vision;

Countries

China

Contacts

Public ContactWang Lulu

Henan Provincial Eye Hospital

13526685691@qq.com+86 135 2668 5691

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026